Health News Updates 12 October 2012

Meningitis: Pharmacy in outbreak violated license: “The compounding pharmacy at the center of the fungal meningitis outbreak was not following the requirements of its state license, according to a spokesperson for the Massachusetts Department of Public Health. The New England Compounding Center in Framingham, Mass., shipped more than 17,000 vials of a steroid – now implicated in the outbreak – to pain clinics in 23 states. But Madeleine Biondolillo, MD, director of the state’s Bureau of Health Care Safety and Quality, said the company was meant to make up drugs only in response to a doctor’s prescription for an individual patient. ‘This organization chose to apparently violate the licensing regulations under which they were allowed to operate,’ Biondolillo told reporters in a telephone news conference Thursday. An FDA spokesman, Deborah Autor, JD, told MedPage Today the agency has legal remedies available, including the ability to seize products and to lay criminal charges, but she did not elaborate further. A 2006 warning letter to the company, charging it was acting more like a drug manufacturing firm than a compounding pharmacy, elicited assurances that patient safety was being protected and that applicable laws and regulations were being obeyed, Autor said. If the current investigation proves otherwise, she said, ‘we will hold people accountable appropriately’. She added that the agency has had its eye on the company for some time. ‘We’ve been there repeatedly,’ she said. The company has now recalled all three lots of the contaminated steroid, used mainly to control back pain, as well as all of its other products, and is no longer carrying on production….State and local health officials have now contacted more than 12,000 of the estimated 14,000 people exposed to the steroid, which is thought to be contaminated by one or more species of fungus.” (Michael Smith, MedPage Today)

The placebo response occurs outside of conscious awareness, study finds: “A new study demonstrates that the placebo and nocebo responses to pain may be activated by subliminal cues, thought to occur outside of a person’s conscious awareness. Placebo and nocebo responses are the clinical change in a patient’s condition after a treatment that has no active components. A placebo has a beneficial effect on the patient; a nocebo has a negative one. Researchers have long believed that placebo and nocebo responses are associated with a person’s conscious thoughts, beliefs, or expectations of outcomes. However, this study builds on the growing evidence suggesting that these responses can be triggered by cues that are not consciously perceived. The study was funded in part by NCCAM and is published in the journal Proceedings of the National Academy of Sciences. Clinical trials often include comparison of a treatment to a placebo, so that the true and specific value of the treatment can be accurately measured compared to the effect of the placebo. This is particularly important in clinical trials measuring subjective patient-reported outcomes, which, in general, are more strongly affected by the placebo response. There are many questions about the mechanisms by which placebos operate, their role in clinical practice, whether they can – or can ethically – be employed intentionally to improve patient outcomes, and their effects on subjective and objective outcome measures in clinical trials….According to the researchers, [after the experiments],…findings suggest that health-related responses can by triggered by cues that are not consciously perceived, not only for pain, but for other medical conditions that have had demonstrated significant placebo effects…One assumption is that a practitioner could be exhibiting similar subliminal cues that might affect the outcome of treatment.” (NIH/Proceedings of the National Academy of Sciences, September, 2012)

Doctors torn over heart screening for young athletes: “Christopher Storm was a high school freshman and track runner when doctors found an abnormality in his heart. Part of the muscle was thicker than it should have been, making it harder for it to send blood to the rest of his body. The condition, known as hypertrophic cardiomyopathy, is one of the most common causes of sudden cardiac death – when the heart abruptly stops beating. Storm’s disease was caught on an electrocardiogram (ECG), a test of the heart’s electrical signals, done by volunteer doctors who visited his school…as part of a community screening program offered to all students. ‘There was nothing – no light-headedness, no reason for me to believe that anything was wrong,’ Storm, now 17, said almost two years after that test. He believes it may have saved his life, but the idea of screening all young athletes for heart conditions is controversial….so far, date haven’t definitively shown that screening could reliably weed out only the most at-risk kids and do so at a price that wouldn’t break the bank….Sudden cardiac death kills an estimated 100 to 1,000 children in the US every year – an estimate that’s so wide because reliable records of the deaths haven’t been kept….Some experts believe that if more young athletes were screened early on, a number of those deaths could be prevented….The American Heart Association recommends a physical and history only for kids starting sports. ‘I certainly understand the desire to want to do something, but we need to be cautious about that,’ said Dr. Jonathan Kaltman, a medical officer at the National Heart, Lung and Blood Institute in Bethesda, Maryland. ‘We need to be able to confidently say that we’re doing more good than harm before launching a screening program that’s going to affect many, many lives.” Depending on the abnormality detected, treatment can include heart medications, surgery or exercise restrictions only. Screening isn’t perfect – initial ECG screening added to a traditional history and physical would cost $117 per athlete, really adding up when millions of kids are screened. (Reuters Health)

Oakland sues US to prevent closing of marijuana dispensary: “The City of Oakland has filed a lawsuit in federal court to prevent the Department of Justice from seizing property leased to the largest medical marijuana dispensary in the country. ‘This lawsuit is about protecting the rights of legitimate medical patients,’ City Attorney Barbara Parker said in a statement on Wednesday, when the suit was filed. ‘I am deeply dismayed that the federal government would seek to deny these rights and deprive thousands of seriously ill Californians of access to safe, affordable and effective medicine’. The civil lawsuit, which the City Council approved, seeks to ‘restrain and declare unlawful’ the forfeiture proceedings against the landlords of the dispensary, Harborside Health Center, stating that Oakland will ‘suffer irreparable harm if the dispensaries are shuttered’….Oakland is the first city to file such a lawsuit amid escalated efforts by federal prosecutors to close the state’s dispensaries. Since last October, the United States attorneys in California have sent hundreds of letters to dispensary owners, landlords and local officials, threatening forfeiture of assets and criminal charges.” Federal officials are calling Harborside a marijuana “superstore”, and one went on to say the larger the dispensary, ‘the greater the likelihood that there will be abuse of the state’s medical marijuana laws, and marijuana in the hands of individuals who do not have a demonstrated medical need’. …Some 500 dispensaries across California have closed in the past year as a result of pressure from federal prosecutors and approximately 1,000 remain open, according to Kris Hermes, a spokesman for Americans for Safe Access, a nonprofit medical marijuana advocacy group. ‘Whether or not this lawsuit is successful,’ Mr. Hermes said, ‘it represents an important push back by local officials who are tired of being bullied by the federal government.” (NY Times)